O NTE de Conselheiro Lafaiete e a implementação das TDIC nas escolas

• Help of DPO from – UCL St Luc Brussels

– CHU UCL Namur (Mme Scobeau)

• May 2018: European Law

– Article 49 derogations for particular situations

– Art 49 point G: registers, public health: no need for informed consent (EXCEPTION!)

• MB/BS 05 sept 2018: Belgian Law 30/07/2018, abrogate 1992 Data protection

– Article 9:PUBLIC HEALTH Responsible of data takes care that designated persons are under contract for condentiality

– contracts under preparation between college and UCL St Luc/Bordet,

… or in cascade with 24 centers.

– Contract between College and FOD-SPF: no response but a yearly contract exists and data = FOD-SPF property

Dear Elekta team,

I was requested to provide you with a summary of what our questions or projects are that can be discussed during the meeting on dec 7^th in Brussels.

BACKGROUND

The COLLEGE OF RADIOTHERAPY is a governmental initiative with appointed physicians (8) who can appoint consultants (physicists, RTTs, …). The mission is to set out national standards of quality and to organize quality controls. The College does not have any controlling or policing role, but rather a role to invite the whole of the radiotherapy community to increase quality.

The College fulfills its role via a set of sub-projects, some of which include :

- A general clinical audit of departments of radiotherapy, where every 5 years every department in the country is visited and audited

- A specific physics- or machine-output audit, with subprojects for specific types of IMRT or stereotactic treatments

- Comparing practices in target volume delineation, helping to develop national guidelines, and verifying that these guidelines are feasible by having national databases of delineated patients with ‘feedback’ to centers as to the difference between the locally delineated case and the (new) guideline.

- Collecting and evaluating a set of national QUALITY INDICATORS (QI).

It is for this last task that we were looking to collaborate. There are 3 types of QI : structure (S-QI) (which is the staffing and the availability of machines), process (P-QI), and outcome (O-QI).

For P-QI and O-QI, data is gathered for individual treatments by the QUALITY MANAGER in each department. These quality managers are paid via a budget of the ‘Cancer Plan’, and there is 1 per department. The individual patient data is first gathered (in most departments) locally on paper reporting forms, with or without the help of clinicians, physicist, dosimetrists, secretaries, … and then copied manually to a web-based platform that the College put into place. This platform has some validity checks at the moment data is inserted to stimulate for higher data quality than before. While in the departments the data can be on a named basis, once in the national database it does not contain patient IDs (pseudo-anonymized data).

Then representatives of the College use this data to derive some QI on a yearly basis, and make a report on the evolution of the quality. There is no ‘name and shame’ policy : every report is anonymous as to which hospital obtained which result. The individual hospitals do however get to know their own results, which they can then compare to the national mean.

Because of this quite labor-intensive and partially manual process of obtaining QI, it was decided to start this project 4 years ago with a limited scope in number and details of gathered data-items per patient or treatment : 3 well defined pathologies were selected, and per pathology the only P-QI registered are related to ‘timely delivery’ (which means registering the date of the multidisciplinary discussion or tumor board, the date of the first visit, the date of simulation, treatment start and –end). Some basic staging-information is also asked for, and RT-prescription data. As for O-QI, some DVH parameters are asked, and a scoring of some short-term toxicity based on CTC (common toxicity criteria). The data is presently asked for 20-25 patients per pathology per department (3 pathologies x 25 patients x 25 departments = 1875 patient datasets).

PRESENT PROJECT

The number of pathologies needs to be seriously increased to cover a larger number of types of treatments. The number of data-items per patient needs to be increased to be able to better interpret results. The number of patients per pathology can be increased to be more representative. It is however impossible to do so based on the presently used tools : PARTIAL AUTOMATION is required, to somehow EXTRACT per patient in each hospital an anonymized readily nationally readable report per treatment series with more data items then at present.

To manage this, we would need software that has ideally the capability to combine data from Mosaiq with data from other sources, transiting or not via Mosaiq. Eg : DVH data.

We know no ready-made solution is at present available, but we hope that in combining these measures or products, further automation than at present will be possible :

- Departments might need to register differently or in different applications some of the data, or the software should be able to extract from other data-sources (eg: toxity data is in EMR, not in Mosaiq)

- DVH-data and scheduling data should be part of the data accessible for extraction

- In case a patient has several RT treatments, the used tools should be able to extract only the relevant data for a specific treatment series, possibly after manual intervention to indicate the scope of the data-search We have had contacts with people managing similar projects in other countries, or with competitive companies who are at present developing tools for data-extraction that can partially help us.

For your information : centralized quality control or centralized data-reporting is not a unique Belgian need or project. In, some US States, The Netherlands projects exist at present, but possibly based on software OUTSIDE of what Elekta and Varian had on offer in the past. With recent developments, we believe that we need to explore all options to COLLABORATE to help with such national data-gathering. If successful this will greatly aid the College, the quality of RT in Belgium, but this can also be published or used as an example outside Belgium. We are sure there will be a greater need for such systems in the future.

As you will hear during the discussion, we do NOT have a complete ‘tender’ written out. We are between us not completely in agreement (yet) on the scope and width and timing of the project. We are rather in the phase of BRAINSTORMING, to identify the potential role of the college, the possible Belgian e-health initiatives and the cancer registry, and also hopefully the important technical role you can have as industry in facilitating this. Our goals might need to be adapted to the (technical) feasibility, available finances, willingness to collaborate between the multiple partners, …

Maybe you can check before the meeting if any data-extraction tools you have on offer, have access to DVH data as far as full plans have been exported to Mosaiq, and to the scheduling.

We also hope that if some software would be available in the near future, a TEST SITE can be identified to explore the possibilities.

See you on Dec 7^th. For the College, Nicolas Jansen

22-1-2019

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Project : towards automated QI extraction based on individual data items (per patient)

! Previous situation

! Present situation

! First steps towards automation

Project : towards automated QI extraction based on individual data items (per patient)

! Previous situation

! Present situation

! First steps towards automation

Project : towards automated QI extraction based on individual data items (per patient)

! Previous situation (first 2 years)

! Pilot project with …

! limited number of pathologies (3)

! limited number of patient-treatments per pathology (5-20-25-…)

! limited number of data-items per treatment

! Many manual steps

! manually noting data items on forms in most departments

! item-by-item encoding by QM (quality managers)

! manual creation of report

! Simple platform

! relational database filled in locally, send to reference person, copy-paste to global registry

! no automated internal validity control of data-items entered (some missing, wrong or inversed data, …)

22-1-2019

3

Project : towards automated QI extraction based on individual data items (per patient)

! Previous situation

! Proof of concept = OK

! Present situation

! First steps towards automation

! Automation (?), eHealth, big dreams, …

Project : towards automated QI extraction based on individual data items (per patient)

! Previous situation

! Present situation

! First steps towards automation

! Automation (?), eHealth, big dreams, …

Project : towards automated QI extraction based on individual data items (per patient)

! Present situation

! Better methodology

! modified definition of some data-items

! 20 treated patients per pathology

! ‘Red Cap’ platform for more uniform webbased encoding …

! … with some internal validity checks

! analysis centralised with A. Vaandering

! reports for individual departments

! Not ready for evolution because

! At the encoding level in individual departments : many manual steps

! Impossibility to have access to full DVH data (requires pre-definition of what is a usefull parameter)

! …

Project : towards automated QI extraction based on individual data items (per patient)

! Present situation

! Better methodology

! modified definition of some data-items

! 20 treated patients per pathology

! ‘Red Cap’ platform for more uniform webbased encoding …

! … with some internal validity checks

! analysis centralised with A. Vaandering

! reports for individual departments

! Not ready for evolution because

! At the encoding level in individual departments : many manual steps

! Impossibility to have access to full DVH data (requires pre-definition of what is a usefull parameter)

! …

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Local encoding ‘simple’

OIS / RV TPS

paper or electronic form Q

M

centralisation

Local encoding ‘reality’

OIS / RV 1 TPS 1

paper or electronic form Q

OIS / RV 1 TPS 1

Tool should help with : Finding data Configure the tool Help the tool

Curating data when needed

Project : towards automated QI extraction based on individual data items (per patient)

! Previous situation

! Present situation

! First steps towards automation

! Automation (?), eHealth, big dreams, …

22-1-2019

7

Project : towards automated QI extraction based on individual data items (per patient)

! First steps towards automation

! Look for the ‘tool’

! No guarantee of success

! But requirements do exist in other countries

! We have no choice

" Look for help from the industry

" Look for experiences abroad / other specialties

Looking for tools with the industry

! Meetings with VARIAN

! During a College meeting : introduction

! In Ghent on 03-04-2018

Looking for tools with the industry

! Meetings with VARIAN

! In Ghent on 03-04-2018

! VARIAN TEAM

! Athanasia Kanli

! Peter Vereecke

! Patrick Kupelian (radiation oncologist at UCLA)

! COLLEGE TEAM

! Maarten Lambrecht

! Yolande Lievens

! Vincent Remouchamps

! Aude Vaandering

! Nicolas Jansen

! Luigi Moretti

Looking for tools with the industry

! Meetings with VARIAN

! In Ghent on 03-04-2018

22-1-2019

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Looking for tools with the industry

! Meetings with VARIAN

! In Ghent on 03-04-2018

! Oncology360 = core product that can work as an ‘interface’ with other platforms (including EHR, Mosaiq, hospital PACS systems, ...)

! Information needs to be ‘cured’ : Varian boughtEvinance(02-2018)

Looking for tools with the industry

! Meetings with VARIAN

! In Ghent on 03-04-2018

! Information needs to be assembled : Oncology360 interfaces with EHR, or can be helped by :

! Meetings with VARIAN

! In Ghent on 03-04-2018

! Conclusion :

! Oncology360 is a product in development

! integration with other technologies is awaited / necessary

! at present no ready to use product for our needs

! Pilot project to be potentially started in Ghent

Pilot project in Ghent ?

! Meetings with VARIAN

! In Ghent on 03-04-2018

! Contact with Peter Vereecke 20-11-2018 :

! No pilot project started (he understood that we wanted a more local approach)

! Announced first contacts in Antwerp to automate preparation of data for the cancer registry

22-1-2019

11

Looking for tools with the industry

! Meetings with ELEKTA

! In Brussels (Bordet) on 07-12-2018

! Participants

! ELEKTA

! M. Guerschaft

! E. Geerlof

! Possibly conference call wth UK based registry specialist

! COLLEGE

! Aude Vaandering

! Nicolas Jansen

! Florian Charlier

! Vincent Remouchamps

! Frederik Vanhoutte

! …

! Agenda …

Looking for tools with the industry

! Meetings with ELEKTA

! In Brussels (Bordet) on 07-12-2018

! Demand for a vision text what we would potentially require from the industry

! Text prepared, not yet validated

! In Brussels (Bordet) on 07-12-2018

! Elekta has a cancer registry tool presented at ASTRO 2014 (METRIQ)

! Might be the basis for data extraction in Elekta equipped departments who have clinical data in Mosaiq, …

Looking for experiences abroad

! Meeting with MAASTRO team

! In Maastricht on 11-09-2018

! Participants :

! MAASTRO

! Andre Dekker

! Tim Lustberg

! COLLEGE

! Aude Vaandering

! Vincent Remouchamps

! Florian Charlier

! Nicolas Jansen

22-1-2019

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Looking for experiences abroad

! Meeting with MAASTRO team

! In Maastricht on 11-09-2018

! Topics discussed :

! Presentation of he College and our project

! They are impressed by the availability of QM in each department

! Similar QI projects in The Netherlands, but only a specific lungcancer project has a very centralised data collection

! They stress the difficulties of centralising the raw data, and then extracting he QI

! Proposal to use more LOCAL tools and the local QM to collect local QI, and then only send the local QI to a national platform (no individual patient data)

! They underline the difficulties to develop tools that will work in “all”

deparments to extract data : we are encouraged to discuss with Varian and Elekta, but they do not expect ready made tools to be available

Local encoding

QI TRANSFER, NOT COMPLETE PATIENT DATA

! Meeting with MAASTRO team

! In Maastricht on 11-09-2018

! Topics discussed :

! They are preparing a spin-of company of MAASTRO to help individual departments in extracting data (software tools)

! The software tools should manage Dicom, Fhir, …

https://cris.maastrichtuniversity.nl/po rtal/files/30398616/c6220.pdf

Next steps

! Elekta meeting

! Contact Tim Lustberg (after the dissertation)

! Continue with Varian pilot ?

! Continue with Elekta pilot ?

22-1-2019

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